A specificity trial of the diagnostic agent C-Tb

• Research type

  Research Study

• Full title

  A phase IIa specificity trial of the diagnostic agent C-Tb, when given intradermally by the Mantoux technique to healthy volunteers previously vaccinated with BCG

• IRAS ID

  62678

• Contact name

  David JM Lewis

• Eudract number

  2009-017296-17

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a specificity trial of the diagnostic test C-Tb, given as an injection just under the skin to healthy adult volunteers previously vaccinated with BCG, and will collect data on the distribution of the induration response, if any, to C-Tb in this population. The specificity of the C-Tb test will be defined as the relative frequency of subjects in a healthy population who have an induration response < cut-off after a C-Tb test. Tuberculosis continues to be a major cause of illness and death throughout the World. The majority of TB patients are still diagnosed with tools developed over half a century ago such as the injected Tuberculin Skin Test (TST) using Purified Protein Derivate (PPD), and sputum microscopy. However unlike the classical tuberculin PPD which contain a complex mixture of various antigens, C-Tb contains a mixture of two purified antigens, rdESAT-6 and rCFP-10, making C-Tb more specific than PPD. C-Tb has been tested in 42 healthy adult volunteers (2008/2009, Denmark) and in 38 recently diagnosed TB patients (2010, UK) and found to be safe. In this trial, each volunteer will receive a single injection in each arm, one arm will receive C-Tb (0.1 æg/mL) and one arm will receive 2 T.U. Tuberculin. The purpose of skin tests is to raise a small area of inflammation in case of TB immunity. The trial will be conducted at the University of Surrey, under the responsibility of principal investigator Prof David JM Lewis and Site responsible Investigator Dr Hubert Bland (University of Surrey). The study is a single centre trial at the University of Surrey and will continue for approximately one year. Each patient in the study will be participating for approximately one month in total. The trial is funded by Statens Serum Institut (SSI), Denmark

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/109

• Date of REC Opinion

  4 Apr 2011

• REC opinion

  Further Information Favourable Opinion